Study of ISIS 678354 (AKCEA-APOCIII-LRx) in Participants With Hypertriglyceridemia and Established Cardiovascular Disease (CVD)

• Status: Completed
• Trial end date: 2020-02-25
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 678354 and to assess the efficacy of different doses and dosing regimens of ISIS 678354 for reduction of serum triglyceride (TG) levels in participants with hypertriglyceridemia and established CVD or at a high risk for CVD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Akcea Therapeutics
• Collaborator: Ionis Pharmaceuticals, Inc.

Criteria

Key Inclusion Criteria:

• Clinical diagnosis of CVD (defined as documented coronary artery disease, stroke, or peripheral artery disease).

• Fasting serum triglycerides (TG) greater than or equal to (≥) 200 milligrams per deciliter (mg/dL) (≥ 2.3 millimoles per liter (mmol/L)) and less than or equal to (≤) 500 mg/dL (≥ 5.7 mmol/L) at Screening.

• Fasting TG ≥ 200 mg/dL and ≤ 500 mg/dL at Qualification visit.

• Must be on standard-of-care preventative therapy for known CVD risk factors.

Key Exclusion Criteria:

• Within 6 months of Screening: acute coronary syndrome, major cardiac surgery, or stroke/transient ischemic attack (TIA).

• Within 3 months of Screening: coronary, carotid, or peripheral arterial revascularization, major non-cardiac surgery, or lipoprotein apheresis.

• Heart failure New York Heart Association (NYHA) class IV.

• Type 1 diabetes mellitus.

• Type 2 diabetes mellitus with any of the following:

• Newly diagnosed within 12 weeks of Screening.

• Glycated hemoglobin (HbA1c) ≥ 9.0% at Screening.

• Recent change in anti-diabetic pharmacotherapy (change in dosage or addition of new medication within 12 weeks of Screening [with the exception of ± 10 units of insulin].

• Body Mass Index (BMI) greater than (>) 40 kilograms per square meter (kg/m^2).